Blincyto Dosage/Direction for Use

Treatment of MRD-positive B-cell Precursor ALL: A treatment course consists of 1 cycle of BLINCYTO for induction followed by up to 3 additional cycles for consolidation.
A single cycle of treatment of BLINCYTO induction or consolidation consists of 28 days of continuous intravenous infusion followed by a 14-day treatment-free interval (total 42 days).
See Table 9 for the recommended dose by patient weight and schedule. Patients greater than or equal to 45 kg receive a fixed-dose. For patients less than 45 kg, the dose is calculated using the patient's body surface area (BSA). (See Table 9.)

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Hospitalization is recommended for the first 3 days of the first cycle and the first 2 days of the second cycle. For all subsequent cycle starts and re-initiations (e.g., if treatment is interrupted for 4 or more hours), supervision by a healthcare professional or hospitalization is recommended.
Premedicate with prednisone or equivalent for MRD-positive B-cell Precursor ALL: For adult patients, premedicate with prednisone 100 mg intravenously or equivalent (e.g., dexamethasone 16 mg) 1 hour prior to the first dose of BLINCYTO in each cycle.
For pediatric patients, premedicate with 5 mg/m² of dexamethasone, to a maximum dose of 20 mg prior to the first dose of BLINCYTO in the first cycle and when restarting an infusion after an interruption of 4 or more hours in the first cycle.
For administration of BLINCYTO: See 24-Hour or 48-Hour Infusion of BLINCYTO as follows for infusion over 24 hours or 48 hours.
Treatment of Relapsed or Refractory B-cell Precursor ALL: A treatment course consists of up to 2 cycles of BLINCYTO for induction followed by 3 additional cycles for consolidation and up to 4 additional cycles of continued therapy.
A single cycle of treatment of BLINCYTO induction or consolidation consists of 28 days of continuous intravenous infusion followed by a 14-day treatment-free interval (total 42 days).
A single cycle of treatment of BLINCYTO continued therapy consists of 28 days of continuous intravenous infusion followed by a 56-day treatment-free interval (total 84 days).
See Table 10 for the recommended dose by patient weight and schedule. Patients greater than or equal to 45 kg receive a fixed-dose and for patients less than 45 kg, the dose is calculated using the patient's BSA. (See Table 10.)

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Hospitalization is recommended for the first 9 days of the first cycle and the first 2 days of the second cycle. For all subsequent cycle starts and re-initiation (e.g., if treatment is interrupted for 4 or more hours), supervision by a healthcare professional or hospitalization is recommended.
Premedicate with dexamethasone: For adult patients, premedicate with 20 mg dexamethasone 1 hour prior to the first dose of BLINCYTO of each cycle, prior to a step dose (such as Cycle 1 Day 8), and when restarting an infusion after an interruption of 4 or more hours.
For pediatric patients, premedicate with 5 mg/m² of dexamethasone, to a maximum dose of 20 mg prior to the first dose of BLINCYTO in the first cycle, prior to a step dose (such as Cycle 1 Day 8), and when restarting an infusion after an interruption of 4 or more hours in the first cycle.
For administration of BLINCYTO: See 24-Hour or 48-Hour Infusion of BLINCYTO as follows for infusion over 24 hours or 48 hours.
Dosage Adjustments: If the interruption after an adverse event is no longer than 7 days, continue the same cycle to a total of 28 days of infusion inclusive of days before and after the interruption in that cycle. If an interruption due to an adverse event is longer than 7 days, start a new cycle. (See Table 11.)

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Preparation: It is very important that the instructions for preparation (including admixing) and administration provided in this section are strictly followed to minimize medication errors (including underdose and overdose) [see Precautions].
BLINCYTO can be infused over 24 hours or 48 hours. The choice between these options for the infusion duration should be made by the treating physician considering the frequency of the infusion bag changes and the weight of the patient.
For preparation, reconstitution, and administration of BLINCYTO: See 24-Hour or 48-Hour Infusion of BLINCYTO as follows for infusion over 24 hours or 48 hours.
Aseptic Preparation: Strictly observe aseptic technique when preparing the solution for infusion since BLINCYTO vials do not contain antimicrobial preservatives. To prevent accidental contamination, prepare BLINCYTO according to aseptic standards, including but not limited to: Prepare BLINCYTO in a USP <797> compliant facility.
Prepare BLINCYTO in an ISO Class 5 laminar flow hood or better.
Ensure that the admixing area has appropriate environmental specifications, confirmed by periodic monitoring.
Ensure that personnel are appropriately trained in aseptic manipulations and admixing of oncology drugs.
Ensure that personnel wear appropriate protective clothing and gloves.
Ensure that gloves and surfaces are disinfected.
Package Content: 1 package BLINCYTO includes 1 vial of BLINCYTO and 1 vial of IV Solution Stabilizer.
Do not use IV Solution Stabilizer for reconstitution of BLINCYTO. IV Solution Stabilizer is provided with the BLINCYTO package and is used to coat the IV bag prior to addition of reconstituted BLINCYTO to prevent adhesion of BLINCYTO to IV bags and IV tubing.
More than 1 package of BLINCYTO may be needed to prepare some of the prescribed doses.
Incompatibility Information: BLINCYTO is incompatible with di-ethylhexylphthalate (DEHP) due to the possibility of particle formation, leading to a cloudy solution.
Use polyolefin, PVC DEHP-free, or ethyl vinyl acetate (EVA) infusion bags/pump cassettes.
Use polyolefin, PVC DEHP-free, or EVA IV tubing sets.
24-Hour or 48-Hour Infusion of BLINCYTO: Preparation of BLINCYTO Infusion Bag for 24- or 48-Hour Infusion: Verify the prescribed dose and infusion duration for each BLINCYTO infusion bag. To minimize errors, use the specific volumes described in Tables 12 to 14 to prepare the BLINCYTO infusion bag: Table 12 for patients weighing greater than or equal to 45 kg Tables 13 and 14 for patients weighing less than 45 kg.
1. Aseptically add 270 mL 0.9% Sodium Chloride Injection, USP to the IV bag.
2. Aseptically transfer 5.5 mL IV Solution Stabilizer to the IV bag containing 0.9% Sodium Chloride Injection, USP. Gently mix the contents of the bag to avoid foaming. Discard the vial containing the unused IV Solution Stabilizer.
3. Aseptically transfer reconstituted BLINCYTO [see Reconstitution of BLINCYTO as follows] into the IV bag containing 0.9% Sodium Chloride Injection, USP and IV Solution Stabilizer. Gently mix the contents of the bag to avoid foaming.
Refer to Tables 12 to 14 for the specific volume of reconstituted BLINCYTO.
4. Under aseptic conditions, attach the IV tubing to the IV bag with the sterile 0.2 micron in-line filter.
Ensure that the IV tubing is compatible with the infusion pump.
5. Remove air from the IV bag. This is particularly important for use with an ambulatory infusion pump. Prime the IV tubing only with the prepared solution for infusion. Do not prime with 0.9% Sodium Chloride Injection, USP.
6. Store at 2°C to 8°C if not used immediately [see Storage Requirements as follows]. (See Tables 12, 13 and 14.)

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Reconstitution of BLINCYTO: 1. Add 3 mL of preservative-free Sterile Water for Injection, USP by directing the water along the walls of the BLINCYTO vial and not directly on the lyophilized powder (resulting in a final BLINCYTO concentration of 12.5 mcg/mL).
Do not reconstitute BLINCYTO with IV Solution Stabilizer.
2. Gently swirl contents to avoid excess foaming. Do not shake.
3. Visually inspect the reconstituted solution for particulate matter and discoloration during reconstitution and prior to infusion. The resulting solution should be clear to slightly opalescent, colorless to slightly yellow. Do not use if solution is cloudy or has precipitated.
Administration: Administer BLINCYTO as a continuous intravenous infusion at a constant flow rate using an infusion pump. The pump should be programmable, lockable, non-elastomeric, and have an alarm.
Prepared BLINCYTO infusion bags [see Preparation of BLINCYTO Infusion Bag for 24- or 48-Hour Infusion as previously mentioned] should be infused over 24 hours or 48 hours.
The starting volume (270 mL) is more than the volume administered to the patient (240 mL) to account for the priming of the IV tubing and to ensure that the patient will receive the full dose of BLINCYTO.
Infuse BLINCYTO solution according to the instructions on the pharmacy label on the prepared bag at one of the following constant infusion rates: Infusion rate of 10 mL/hour for a duration of 24 hours, OR Infusion rate of 5 mL/hour for a duration of 48 hours.
The BLINCYTO solution must be administered using IV tubing that contains a sterile, non-pyrogenic, low protein-binding, 0.2 micron in-line filter.
Important Note: Do not flush the BLINCYTO infusion line or intravenous catheter, especially when changing infusion bags. Flushing when changing bags or at completion of infusion can result in excess dosage and complications thereof. When administering via a multi-lumen venous catheter, BLINCYTO should be infused through a dedicated lumen.
At the end of the infusion, any unused BLINCYTO solution in the IV bag and IV tubing should be disposed of in accordance with local requirements.
Storage Requirements: The information in Table 15 indicates the storage time for the reconstituted BLINCYTO vial and prepared infusion bag.
Store lyophilized BLINCYTO and IV Solution Stabilizer vials for a maximum of 8 hours at room temperature in the original carton to protect from light [see Storage]. (See Table 15.)

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